Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000047594
Ethics application status
Approved
Date submitted
1/02/2006
Date registered
1/02/2006
Date last updated
1/02/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Enhancing health after surgery for breast cancer
Scientific title
Multidimensional exercise to mitigate the effects of adjuvant therapy following surgery for breast cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 1009 0
Condition category
Condition code
Cancer 1085 1085 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Strength, balance and endurance exercise program.

Both programs are home self management programs to be completed over a 6 month period.
Intervention code [1] 875 0
Treatment: Other
Comparator / control treatment
The comparison group is a flexibility and relaxation program.
Control group
Active

Outcomes
Primary outcome [1] 1450 0
Quality of life
Timepoint [1] 1450 0
At 3 and 6 months
Secondary outcome [1] 2587 0
Fatigue
Timepoint [1] 2587 0
At 3 and 6 months.
Secondary outcome [2] 2588 0
Physical activity levels
Timepoint [2] 2588 0
At 3 and 6 months.
Secondary outcome [3] 2589 0
Direct and indirect health costs
Timepoint [3] 2589 0
At 3 and 6 months.
Secondary outcome [4] 2590 0
Body composition
Timepoint [4] 2590 0
At 3 and 6 months.
Secondary outcome [5] 2591 0
Balance
Timepoint [5] 2591 0
At 3 and 6 months.
Secondary outcome [6] 2592 0
Strength
Timepoint [6] 2592 0
At 3 and 6 months.
Secondary outcome [7] 2593 0
Lymphoedema
Timepoint [7] 2593 0
At 3 and 6 months.
Secondary outcome [8] 2594 0
Range of motion (shoulder).
Timepoint [8] 2594 0
At 3 and 6 months.

Eligibility
Key inclusion criteria
Breast cancer surgery- undertaking adjuvant therapy.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe cardiac disease- Uncontrolled hypertension- Orthopaedic contraindications to exercise.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
economic evaluation
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1189 0
Other Collaborative groups
Name [1] 1189 0
Princess Alexandra Hospital Cancer Collaborative Group
Country [1] 1189 0
Australia
Primary sponsor type
Individual
Name
Dr Terry Haines
Address
Country
Secondary sponsor category [1] 1047 0
Individual
Name [1] 1047 0
Dr Neil Wetzig
Address [1] 1047 0
Country [1] 1047 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2504 0
Princess Alexandra Hospital
Ethics committee address [1] 2504 0
Ethics committee country [1] 2504 0
Australia
Date submitted for ethics approval [1] 2504 0
Approval date [1] 2504 0
Ethics approval number [1] 2504 0

Summary
Brief summary
This program intends to compare the effectiveness of two health programs (one an intervention program, one an active control) for enhancing the quality of life of women who have undergone surgery for breast cancer in the 6 months following surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36017 0
Address 36017 0
Country 36017 0
Phone 36017 0
Fax 36017 0
Email 36017 0
Contact person for public queries
Name 10064 0
Dr Terry Haines
Address 10064 0
c/o Physiotherapy Department
Geriatric and Rehabilitation Unit (GARU)
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba QLD 4102
Country 10064 0
Australia
Phone 10064 0
+61 7 32406713
Fax 10064 0
Email 10064 0
[email protected]
Contact person for scientific queries
Name 992 0
Dr Terry Haines
Address 992 0
c/o Physiotherapy Department
Geriatric and Rehabilitation Unit (GARU)
Princess Alexandra Hospital
Ipswich Rd
Woolloongabba QLD 4102
Country 992 0
Australia
Phone 992 0
+61 7 32406713
Fax 992 0
Email 992 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.